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EFFEXOR XR SHOWN EFFECTIVE IN TREATING GAD SYMPTOMS.

Effexor XR (venlafaxine HCl) Extended-Release Capsules, the only antidepressant indicated to treat generalized anxiety disorder (GAD), is also the first and only medication to demonstrate long-term efficacy and safety in this condition, according to new data published in the Journal of the American Medical Association.

This new study is the first placebo-controlled trial to demonstrate the long-term benefit of any drug class in treating patients diagnosed with GAD. In the study, 69 percent or more of patients treated with Effexor XR showed significant improvements in symptoms of GAD for up to six months, compared with 42 to 46 percent given a placebo.

"These data represent a milestone in the treatment of GAD since they demonstrate, for the first time, the long-term benefits of any drug class in treating this condition," said lead author Alan J. Gelenberg, M.D., professor and head of the Department of Psychiatry, University of Arizona College of Medicine. "As GAD continues to be a highly prevalent, chronic anxiety disorder, robbing many people of a normal, healthy life at home and at work, it is important to find treatments that provide effective long-term symptom relief. Effexor XR may potentially offer patients an alternative to the current treatments, without causing the drowsiness or potential dependence that may be associated with other anti-anxiety medications."

GAD is one of the most common anxiety disorders, affecting approximately five percent of Americans -- most of whom are women -- at some point in their lives. Symptoms include excessive anxiety, worry, and tension that have persisted for at least six months. In many instances, patients with generalized anxiety disorder (GAD) also experience symptoms of clinical depression. Effexor XR -- currently the only antidepressant approved as a treatment for both major depressive disorder and GAD -- inhibits the reuptake of both serotonin and norepinephrine, the two main neurotransmitters involved in anxiety and depression.

Clinical Study Findings

This randomized, double-blind, placebo-controlled trial evaluated the short- and long-term efficacy and safety of Effexor XR in treating symptoms of GAD. In the study, 251 patients with GAD without depression or any other significant psychiatric disorder were treated for up to six months with a daily dose between 75 and 225 milligrams (mg) of Effexor XR or a placebo. Response was measured using common psychiatric measures, such as the Hamilton Anxiety Scale (HAM-A).

Significant differences in GAD symptoms, such as anxious mood and tension, were observed between patients given Effexor XR and those given a placebo. These differences were maintained throughout the 28 weeks of the trial. Additionally, fewer patients treated with Effexor XR discontinued treatment due to a lack of response (8 percent versus 22 percent in the placebo group). In the study, adverse events were consistent with those reported in the labeling for Effexor and Effexor XR. The most common adverse events were anorexia, constipation, dizziness, dry mouth, nausea, sexual dysfunction, somnolence, and sweating; however, with continued long-term therapy with Effexor XR (day 57 to day 196), most of these adverse events subsided.

"These latest data indicate that for patients with GAD, Effexor XR is effective for use over the long term," Dr. Gelenberg said. "This is significant because sustained treatment with Effexor XR not only will help to reduce the daily symptoms of GAD to help patients get well, it may also optimize a patient's chances of long-term recovery from this devastating illness -- potentially diminishing the window to an eventual relapse, or thwarting the possible development of other negative consequences, such as co-morbid depression."

The study was funded by Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation.

About Generalized Anxiety Disorder

Anxiety disorders, which include generalized anxiety disorder (GAD), affect more than 19 million Americans at a cost of more than $46 billion each year, according to the National Institute of Mental Health. GAD is considered to be the most chronic of the anxiety disorders. It is estimated to be four times more prevalent than panic disorder and three times more prevalent than social phobia. GAD has been associated with decreased employment, increased reliance upon public assistance, impaired social life and low ratings of life satisfaction. When left untreated, GAD often leads to other psychiatric disorders, including major depressive disorder, which can occur in as many as 40 percent of patients. Therefore, early treatment of GAD symptoms also may be important for preventing subsequent depression.

About The University of Arizona Health Sciences Center

The University of Arizona Health Sciences Center (AHSC) includes the UA Colleges of Medicine, Nursing, Pharmacy, and Public Health; the UA School of Health Professions; University Medical Center, Arizona's primary teaching hospital; an AHSC Phoenix Campus; and 11 Centers of Excellence. AHSC provides millions of dollars to the state's economy, employs more than 5,000 people and attracts more than $85 million in research grants and gifts each year. AHSC is home to a diverse student body exploring a wide variety of health care disciplines. More than 2,000 undergraduates study such subjects as biochemistry, pathology, physiology and health education. Nearly 500 graduate students pursue degrees in public health, biomedical engineering, pharmacology and cell biology.

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Publication:Biotech Business
Date:Aug 1, 2000
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